Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-99
SponsorSan Diego State University

About this trial

This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Publicly-funded

Providing outpatient or school-based psychotherapy services to children

Have at least 8 mental health providers on staff

Employed as staff or trainee at a participating program

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unstuck and On Target

    Behavioral

    Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.

  • Unified Protocol for Children

    Behavioral

    Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Treatment groups

672 Participants
are divided into 2 treatment groups
Group A: Unstuck and On TargetActive comparator 1 intervention
Group B: Unified Protocol for ChildrenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Child Mental Health Symptoms

Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.

Time frame
Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
2

Externalizing Behaviors

Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.

Time frame
Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
3

Evidence-based Intervention Fidelity

A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.

Time frame
During 6-month EBI implementation
4

Evidence-Based Intervention Training Engagement

Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).

Time frame
6-months post-EBI implementation

Secondary outcomes

1

Evidence-Based Intervention Reach

Therapists will report on evidence-based intervention (EBI) reach as operationalized by the number and types of clients (e.g., presenting problem, diagnostic profile) of clients treated with EBI, including specific components used. Measure was adapted from prior work and used in the PI's feasibility trial.

Time frame
6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation
2

Psychotherapy Quality

Therapists will complete the Evidence-Based Practice Concordant Care Assessment-Therapist Report (ECCA). With funding from NIMH (R01MH100134; PI: Brookman-Frazee/Lau), ECCA was developed and validated as a pragmatic measure of evidence-based strategy delivery in psychotherapy sessions useful in indexing mental health quality of care. It has internal consistency and inter-rater reliability. Therapists will complete weekly regarding strategies within a given session with a participating client.

Time frame
6-months post-EBI implementation

Other outcomes

1

Clinical Mediator: Changes in Executive Functioning, BRIEF-II

Changes in executive functioning will be examined using several measures of executive functioning, including the Brief Rating Inventory of Executive Function-2nd Edition (BRIEF-II)- Parent Report, a 63-item rating scale supported by RDoC Working Group that measures real-world EF skills. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

Time frame
Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
2

Clinical Mediator: Changes in Executive Functioning, EFCT

Changes in executive functioning will be examined using several measures of executive functioning, including the Executive Function Challenge Task (EFCT), a standardized, semi-structured assessment of real-world EF abilities. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

Time frame
Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
3

Clinical Mediator: Changes in Executive Functioning, DCCS

Changes in executive functioning will be examined using several measures of executive functioning, including the NIH toolbox Dimensional Change Card Sort test (DCCS), a standard, lab-based task for assessing cognitive flexibility. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

Time frame
Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
4

Clinical Mediator: Changes in Emotion Regulation

Changes in Emotion Regulation will be examined using the Emotion Dysregulation Inventory (EDI), a 30-item parent-report ratings scale measuring emotion regulation.

Time frame
Pre-EBI implementation, 6-months post-EBI training, 12-month follow-up after EBI implementation

Sponsors and contacts

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San Diego State University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of California, San Diego

Collaborator

University of Colorado, Denver

Collaborator